Ivabradine in the Acute Management of Cardiogenic Shock - IVASHOCK-a Double-blind Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Hierarchical Composite Clinical Recovery at 72 Hours Assessed Using the Win Ratio
研究概览
简要总结
Brief Summary:
The IVASHOCK trial investigates whether ivabradine can achieve at least one-class improvement in SCAI cardiogenic shock classification compared to placebo, and evaluates its safety profile in patients with cardiogenic shock (CS).
Primary Objectives:
- To determine whether ivabradine improves SCAI shock classification by at least one class from baseline within 72 hours compared to placebo
- To assess whether ivabradine facilitates earlier weaning from vasoactive and inotropic support compared to placebo
Safety Endpoints:
Adverse events monitored include: sinus node dysfunction, new-onset atrial fibrillation or atrial flutter, atrioventricular block, drug-related hypotension, and ventricular arrhythmia.
Participant Schedule:
Participants will receive ivabradine or placebo orally every 12 hours for 3 days.
Hemodynamic and metabolic assessments will include:
Arterial pH, central venous oxygen saturation (ScvO2), and serum lactate - every 6 hours on Day 1, then every 8 hours on Days 2 and 3 Heart rate, mean arterial pressure (MAP), vasoactive/inotropic support dose, and urine output - measured on the same timeline
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-75 years diagnosed with STEMI complicated by cardiogenic shock (CS) as defined by SCAI shock classification > C:
- •Signs of Hypoperfusion including:
- •SBP <90 OR MAP <60 OR >30 mmHg drop from baseline AND drugs/device used to maintain BP above these targets
- •Cold, clammy extremities
- •Urine output <30 mL/h
- •pulmonary congestion (either crackles, congestion in chest X-ray or B-lines in lung US)
- •Mixed venous oxygen saturation ≤ 65%
- •Severe Left ventricular (LV) dysfunction or right ventricular (RV) infarction
- •Heart rate (HR) ≥ 100 bpm (Sinus Rhythm) in whom beta-blocker therapy cannot be initiated, including: On inotropic or vasopressor support, Requiring an intra-aortic balloon pump (IABP), With Killip class III or IV, Requiring BiPAP or mechanical ventilation
排除标准
- •Age > 75 years
- •CPR > 12 mints
- •Atrial fibrillation
- •Complete Heart Block
- •Heart rate of < 100 bpm
- •End stage Renal Disease
- •Extensive comorbidities; Prior CVA, Malignancy, Pregnancy or Ongoing Participation in Other Trials
结局指标
主要结局
Hierarchical Composite Clinical Recovery at 72 Hours Assessed Using the Win Ratio
时间窗: 72 hours
The primary outcome will be analyzed using a hierarchical win ratio. Participants will be compared sequentially as follows: (1) greater increase in total shock score from baseline to 72 hours; the score ranges from 0 to 12 and sums four 0-3 components: mean arterial pressure/vasoactive support, mixed venous oxygen saturation, urine output, and arterial lactate, with higher scores indicating better status; (2) less vasoactive/inotropic support at 72 hours, and if the number of agents is equal, the lower total dose; (3) lactate \<2 mmol/L; (4) mixed venous oxygen saturation ≥65%; (5) urine output ≥30 mL/hour; and (6) heart rate \<100 beats/min without symptomatic bradycardia, high-grade atrioventricular block, or new atrial fibrillation/flutter. If participants remain equal after all components, the comparison will be a tie. The effect will be reported as the win ratio (ivabradine wins/placebo wins).
次要结局
未报告次要终点
研究者
Dr Asim Ali
Senior Registrar
National Institute of Cardiovascular Diseases, Pakistan